Kornimate/medical-research-clean huggingface dataset:
retrospective study of glucose monitoring for glycemic control in patients with gsdia

Conditions: Glycogen Storage Disease Type IA

Summary: the primary objective of this study is to assess the percentage of time patients were in normal glucose control.

retrospective dexcom g6 icgm data stored in the clarity cloud from eligible patients will be accessed and downloaded, stripped of patient-identifying information and provided to the contract research organization (cro) to review prior to sending to the sponsor for analysis of glycemic control. the cro will ensure data shared with the sponsor is de-identified and transferred over a secure file transfer platform. further, remote site specialists (rsss) from the cro will work with the healthcare providers (hcps) from participating sites to obtain additional patient data including medical history, prescribed diet, cornstarch/glycosade use and demographic data directly, if available, from the medical charts and will enter this information into an electronic data capture (edc) system.

Eligibility criteria:
inclusion criteria: * diagnosis of gsdia confirmed by either liver biopsy or molecular testing. * currently using the dexcom g6 icgm for glycemic control and with approximately one (1) month of cgm data available on the dexcom clarity cloud and have authorized sharing of data with thereferral center through the dexcom clarity app. exclusion criteria: * presence or history of any disease, condition or chronic medication that, in the investigator's opinion, would significantly affect interpretation of study results. * use of any investigational product or investigational medical device within 30 calendar days preceding screening or before completion of all scheduled study assessments during study enrollment.

Keywords: dexcom g6 icgm glucose metabolism disorder cgm continuous glucose monitoring
a study of bevacizumab in combination with standard of care treatment in participants with advanced non-squamous non-small cell lung cancer (nsclc)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (avastin) in combination with standard of care (soc) treatment in participants with advanced non-squamous nsclc. participants will be enrolled at documentation of progression of disease (pd) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to pd. participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus soc treatment or soc treatment alone.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-squamous nsclc * documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of bevacizumab (monotherapy) maintenance treatment prior to first progression of disease * no treatment interruption of bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of cycle 1 of second line treatment * randomization within 4 weeks of progression of disease * at least one unidimensionally measurable lesion meeting recist v1.1 criteria * eastern cooperative oncology group (ecog) performance status 0-2 * participants with adequate hematological, liver, and renal function * female participants must not be pregnant or breast-feeding. female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s) exclusion criteria: * mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component * epidermal growth factor receptor (egfr)-mutation-positive disease according to local laboratory testing * history of hemoptysis greater than or equal to (\>/=) grade 2 within 3 months of randomization * history or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding * major cardiac disease * treatment with any other investigational agent within 28 days prior to randomization * known hypersensitivity to bevacizumab or any of its excipients, or any soc drugs foreseen * malignancy other than nsclc within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or soc drug
to evaluate the efficacy and safety of jlp-2002 on symptoms of overactive bladder

Conditions: Overactive Bladder

Summary: overactive bladder (oab) is a clinical condition characterized by urgency (i.e., urinary urinary urinary urgency that is difficult to delay and unbearable) with or without urge incontinence, usually associated with frequency and nocturia. the main drug class used is antimuscarinics, and the clinical utility of antimuscarinic drugs is limited due to its mild efficacy and poor tolerability due to side effects of mechanisms such as dry mouth and constipation. in addition to poor tolerability and mild efficacy, recent literature suggests that long-term use of anticholinergics is associated with cognitive impairment and dementia. therefore, the purpose of this study was to evaluate the treatment effect of overactive bladder symptoms through the change in the average number of urination per day after administration of jlp-2002, a beta 3-adrenergic receptor (β3-ar) agonist with an effective alternative mechanism, for 12 weeks.


Eligibility criteria:
inclusion criteria: 1. those who are fully informed of this study and then completely understand its contents, voluntarily decide to participate in this study, and give written consent to follow instructions 2. males or females aged 19 years or older at the time of written consent 3. those who have already experienced symptoms of overactive bladder (oab)\* for 6 months or more at the time of screening 4. those who are able to read, understand, and write in a voiding diary and a questionnaire 5. those who are able to go to the toilet on foot without other's help exclusion criteria: 1. those who have a history of malignancies within 3 years before screening 2. those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer) 3. males who were previously or are currently diagnosed with prostate cancer or whose prostate-specific antigen (psa) level is ≥ 4ng/ml within 1 year before screening or at screening 4. those with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values 5. pregnant or lactating women 6. those whose systolic blood pressure (sbp) is ≥160mmhg; diastolic blood pressure (dbp) is ≥100 mmhg; or pulse is ≥110 bpm at the time of screening and randomization 7. those who received other investigational products or investigational devices within 30 days before screening 8. those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests
study of cetuximab, oxaliplatin, 5-fu/lv versus oxaliplatin, 5-fu/lv in patients with previously treated metastatic, egfr-positive colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to compare overall survival in patients with previously-treated metastatic, epidermal growth factor receptor (egfr)-positive colorectal cancer treated with oxaliplatin, 5-fluorouracil and leucovorin (folfox4) and cetuximab with folfox4 alone.


Eligibility criteria:
inclusion criteria: * documented colorectal cancer which is egfr-positive and is metastatic. * prior irinotecan, alone or in combination, as first-line treatment of metastatic disease. exclusion criteria: * a serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy. * known dihydropyrimidine dehydrogenase (dpd) deficiency. * known metastases in the central nervous system. * symptomatic sensory or peripheral neuropathy. * more than one prior chemotherapy regimen for the treatment of metastatic colorectal cancer. * prior oxaliplatin therapy. * prior cetuximab or other therapy which targets the egf pathway. * prior chimerized or murine monoclonal antibody therapy.
study to determine the effectiveness of risperidone in bipolar disorder in children and adolescents

Conditions: Bipolar Disorder

Summary: a clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.

subjects will be aged 10 to 17 years with a diagnosis of bipolar i disorder and suffering from a current mixed or manic episode. on enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. the maximum tolerated dose will be given for the last 12 days of the study. risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 weeks.

Eligibility criteria:
inclusion criteria: * current primary diagnosis of bipolar i disorder, mania or mixed type * aged between 10 and 17 years * young mania rating scale score greater than or equal to 20 at screening and baseline exclusion criteria: * known or suspected history of substance dependence * significant risk for suicidal or violent behavior * received electroconvulsive treatment within 4 weeks of baseline * received a depot antipsychotic within 2 treatment cycle before baseline * is unable to swallow medication taken in the form of tablets * has a positive result for a urine drug screen done at baseline * known or suspected seizure disorder * hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening * known or suspected history of hypersensitivity or intolerance to risperidone * history of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent

Keywords: bipolar mania manic depressive manic depressive bipolar mania risperidone adolescents children
strategic management to optimize response to cardiac resynchronization therapy registry

Conditions: Heart Failure

Summary: to learn in a general cardiac resynchronization therapy defibrillators (crt-d) population, which optimization techniques are used and how effective they are. it will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. a subset of smart registry subjects will contribute to the ng4 post market clinical follow up (pmcf) cohort whose objective is collecting data on the ng4 crt-d features and device usage in a real world setting and monitor long term safety associated with these devices to support ce mark.


Eligibility criteria:
inclusion criteria: * subject implanted or upgraded with a ng3 or ng4 crt-d device connected with any manufacturer quadripolar lv lead based on bsc labeling for devices in specific geographies. * subjects must be enrolled between 1 and 21 calendar days post crt-d implantation procedure. * subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws * subject is willing and capable of complying with follow-up visits and procedures as defined by this protocol exclusion criteria: * subject with documented life expectancy of less than 12 months * subject currently on the active heart transplant list or has a current left ventricular assist device or other assist device (mechanical circulatory support device). * subject who have had a pre-existing crt device * subject enrolled in any other concurrent clinical trial without prior written approval from bsc clinical trial manager * women of childbearing potential who are or might be pregnant at time of study enrolment * any contra-indication to receive a crt-d device per local guidelines
efficacy and safety of tofacitinib in patients with prurigo nodularis

Conditions: Prurigo Nodularis; Itch

Summary: the goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.the main questions it aims to answer are 1. whether tofacitinib is effective in treating prurigo nodularis in the longpterm. 2. whether tofacitinib is safe in prurigo nodularis patients in the longpterm.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old; 2. patients diagnosed with pn with a duration of more than 6 months; 3. presence of at least 10 pruritic nodules; 4. a worst itch-numeric rating scale (wi-nrs) score ≥7 one week before study; 5. a history of more than 2 weeks of ineffective topical glucocorticoid treatment or antihistamine therapy; 6. signed informed consent and cooperated with the follow up and complied the study protocol. exclusion criteria: 1. current used of biologic, systemic glucocorticoid or immunosuppressive agents; past used of jak inhibitors; 2. were pregnant or lactating; 3. abnormal findings for patients' complete blood count, liver functions, and kidney function tests; 4. presence of any infection or inflammatory; presence of active tumors or an increased risk of tumor complications； 5. systemic comorbidities that could interfere with or complicate study assessments. 6. those experiencing atopic dermatitis within 6 months were excluded from this study.
study of irx4204 for treatment of early parkinson's disease

Conditions: Parkinson's Disease

Summary: this is a single site, open-label study designed to examine dopamine transporter density using \[123i\]β-cit spect imaging before and following treatment with irx4204 for a 30-day period in early parkinson's disease patients. in addition, clinical evaluations will be performed to evaluate the effect of irx4204 treatment on the motor and cognitive symptoms of pd.

fifteen patients with early pd were enrolled in this open label study, in 3 cohorts of 5 patients each, treated with irx4204 at 5 mg/day, 10mg/day, or 20 mg/day. patients were administered irx4204 orally once daily. baseline assessments were performed for total motor score, and unified parkinson's disease rating scale (updrs). follow-up assessments of these clinical outcome measures were performed at 14 and 29 days of treatment. \[123\]β-cit spect imaging for assessment of dopamine active transporter (dat) expression was performed at baseline, and on day 30 of irx4204 treatment. patients had clinical hematology and chemistry laboratory tests, and recording of adverse events, performed at baseline and at follow up visits.

Eligibility criteria:
inclusion criteria: 1. participant is 40-80 years of age, inclusive. 2. participant has a clinical diagnosis of pd based on the uk brain bank criteria. 3. participant has hoehn and yahr stage \< 3. 4. participant may be treated with pd symptomatic therapy on a stable dose for at least 30 days prior to the screening visit. dose levels of pd symptomatic therapies will remain stable through the patient's participation in the study, unless a change of dose level is indicated because of adverse events. 5. participant must be willing and able to provide informed consent. 6. females must be of either non-child bearing potential based on: * post-menopausal for at least 2 years, or * surgically sterilized if of child bearing potential, must be neither pregnant or breastfeeding at screening, and must be willing to avoid pregnancy by using medically accepted contraception (use of an intrauterine device or use of a double barrier method when engaging in sexual intercourse with a male partner) for 4 weeks prior to and 4 weeks following the last dose of study medication. exclusion criteria: 1. has any form of parkinsonism other than idiopathic pd 2. are currently experiencing motor fluctuations (end of dose wearing off or dyskinesias) reflective of later stage pd 3. has evidence of dementia or significant cognitive dysfunction 4. has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness. 5. the subject has any disorder that may interfere with drug absorption, distribution, metabolism or excretion. 6. the subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease. 7. pregnancy or breastfeeding

Keywords: pd parkinson's disease
high frequency rf current effects on muscle pain and function

Conditions: Transcutaneous Electric Nerve Stimulation; Chronic Low-back Pain; Hamstring Injury; Muscle; Injury, Quadriceps (Thigh); Physical Therapy; Calf Muscle Pulled

Summary: the purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "tecar") on pain and functional movement in individuals with a musculoskeletal injury or pain. the participants will be assigned into an experimental or a control group and outcome measures will be measured prior to, after, 24 and 48 hours following a single intervention session (acute effects) as well as 3 and 6 months after the intervention (chronic effects).

the purpose of this study is to examine the acute and chronic effects of high frequency electrical current transfer (frequently called "tecar") on pain and functional movement in individuals with a musculoskeletal injury or pain. participants referred for muscle strain injury (hamstring, quadriceps, gastrocnemius) or chronic low back pain will be randomly allocated into one of the three groups: an experimental group (muscle injuries), experimental group (low back pain) and a control group. the project is divided in two phases. in the first phase, the acute effects of tecar therapy will be examined. outcome measures will be obtained prior to, after, 24 and 48 hours following a single intervention session. the intervention consists of 20-min electrical energy transfer session (capacitive mode, 0.5 mhz radiofrequency, intensity 40%) or a typical transcutaneous electrical stimulation (tens, asymmetric biphasic mode, rectangular pulse, f = 80hz) protocol. in the chronic stage, participants will receive 10 sessions (3 times a week) receiving either protocol while outcome measurements will be obtained before, immediately, 3 and 6 months after the intervention. analysis of variance designs will be used to compare differences in each outcome between groups at different measurement sessions. the alpha level is set to p \<0.05.

Eligibility criteria:
muscle injury group inclusion criteria: * acute hamstring or quadriceps or calf strain injury * age above 18 years exclusion criteria: * other injury or musculoskeletal condition * any observed organ dysfunctions * receipt of medication or treatment for the past 3 months low back pain group inclusion criteria * pain between bottom of ribs and buttock creases * incidents for at least half the days in the past six months * visual analogue pain score equal or greater than 4/10 * pain incidents for for less than half the days in the past six months exclusion criteria: * radiographic evidence of inflammatory disease affecting the spine * fracture * important genetic structure abnormality in the spine * pregnancy * use of medication that might influence heart rate and/or blood pressure * psychiatric disorders * receipt of medication or treatment for the past 3 months * no neurologic deficits (sensory, motor, or reflexes)

Keywords: sport injuries tecar therapy low back pain muscle injury
near-infrared spectroscopy: differences in placental oxygenation in relation to ultrasound maturation grade in physiological term pregnancies

Conditions: Placenta Diseases

Summary: the aim was to compare placental oxygenation in low risk, uncompli-cated, term pregnancies measured by near-infrared spectroscopy (nirs) in relation to the placental maturity grade determined by ultrasound assessment according to grannum scale. the study included 34 singleton subjects divided into two groups accord-ing to placental maturation: low grade (grannum 0-1; n=10) and high grade (gran-num 2-3; n=24). in each study subjects, measurement was performed at two sites: (a) test site above the central part of the placenta, and (b) control site out of placenta on lower abdomen, in medial line, 3 cm from the symphysis. student's t-test was used to compare tissue oxygenation index (toi) values among the study groups. the normality of distribution was demonstrated by the kolmogorov-smirnov test.


Eligibility criteria:
inclusion criteria: singleton pregnancies low-risk pregnancies uncomplicated pregnancies term pregnancies (37th to 41+6 weeks of gestation) anterior placental localization abdominal wall of less than 3cm thickness. exclusion criteria: complicated pregnancies pre-term pregnancies abdominal wall tick \> 3cm

Keywords: near-infrared spectroscopy placenta oxigenations placenta maturity